Junel News

Junel Q&A

BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

Combined continuous ethinyl estradiol/norethindrone acetate does not improve forearm blood flow in postmenopausal women at risk for cardiovascular events: a pilot study. [2007.09]OBJECTIVE: This study sought to determine whether combined continuous ethinyl estradiol and norethindrone acetate, a postmenopausal hormone therapy (HT) combination designed to have fewer side effects than cyclical therapies and therapies using medroxyprogesterone acetate (MPA), could improve vascular endothelial function in postmenopausal women with risk factors for cardiovascular disease (CVD)... CONCLUSIONS: In this older postmenopausal population with at least one cardiovascular risk factor, treatment with combined continuous ethinyl estradiol and norethindrone acetate failed to improve vascular endothelial function. The agent's proinflammatory effect or subclinical atherosclerosis in this population may have contributed to this finding.

Impact of combined estradiol and norethindrone therapy on visuospatial working memory assessed by functional magnetic resonance imaging. [2006.11]CONTEXT: Hormones regulate neuronal function in brain regions critical to cognition; however, the cognitive effects of postmenopausal hormone therapy are controversial. OBJECTIVE: The goal was to evaluate the effect of postmenopausal hormone therapy on neural circuitry involved in spatial working memory... CONCLUSIONS: Hormone therapy was associated with more effective activation of a brain region critical in primary visual working memory tasks. The data suggest a functional plasticity of memory systems in older women that can be altered by hormones.

Clinical Trials Related to Junel (Norethindrone / Estradiol)

A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen [Recruiting]
The purpose of this study is to investigate the effect of steady-state concentrations of
TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol
and norethindrone (administered once a day) and on the levels of progesterone, luteinizing
hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol
and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen.
Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen
will be studied. Steady-state is a term that means that the drug has been given long enough
so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is
being investigated for the treatment of chronic hepatitis C virus (HCV) infection.
Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in
the body and eliminated from the body. A contraceptive is a method that prevents pregnancy.

It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms
compared to the standard 21/7 regimen.

It is further hypothesized that women using the 24/4 regimen will report greater satisfaction
scores.

Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation [Recruiting]
The purpose of this research study is to gain a better understanding of the changes that may
occur in the breast when a woman uses an oral contraceptive (birth control pill). Some
research indicates that women who use birth control pills with lower amounts of estrogen (a
hormone in the birth control pill) may have lower breast cell growth than women who use
birth control pills with a higher amount of estrogen; this research will examine that in
detail. This research will also test whether the results found in HS-07-00269 can be
confirmed.

TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women. [Recruiting]
The purpose of this study is to investigate the pharmacokinetic interaction between the
combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily.
Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body
and eliminated from the body. Furthermore the short-term safety and tolerability (how well
the body tolerates the drug) of co-administration of TMC278 and ethinylestradiol and
norethindrone, in healthy women, will be assessed.